Globally Harmonized System (GHS)

Introduction

In 1992, the United Nations Conference on Environment and Development (UNCED) adopted an international mandate for a globally harmonized hazard classification and compatible labeling system. The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was first approved by the GHS Sub-Committee in 2002 (published in 2003), and has since been updated every two years. Many international systems were examined by the United Nations as the primary basis for elaboration of the GHS.

Today, the GHS provides an internationally harmonized system for classification of substances and mixtures according to their health, environmental, and physical hazards. It also harmonizes requirements for hazardous communication elements, including labeling and safety data sheets. The benefits of the GHS are a common approach to classifying chemicals, as well as communicating any related hazards to consumers, workers, transport workers, and emergency responders.

Individual countries must determine if and how they will adopt the GHS. Many countries have begun adopting all or parts of the GHS by either integrating it in to their current chemical laws, or by creating new laws. Government agencies in the United States (OSHA) and the European Union (ECHA) are pioneering the adoption of the GHS, and requiring that all products manufactured after June 1, 2015 use the new GHS classification and labeling criteria. Beckman Coulter is committed to maintaining a high level of compliance and diligently working towards meeting the GHS requirements.

The Impact of the GHS

As Beckman Coulter implements the GHS, customers will see changes to Beckman Coulter labeling, Safety Data Sheets (formerly MSDS) and Instructions For Use.

Beckman Coulter products may also be reclassified in respect to the GHS hazard classification. Reclassification could result in the following actions:

Some previously hazardous products will change to non-hazardous; Beckman Coulter will remove any hazard symbols and phrases from labeling

Some previously non-hazardous products will change to hazardous; Beckman Coulter will add a signal word, hazard and precautionary statements and hazard images to labeling as required

For each re-classified product, labels, Safety Data Sheets and Instructions For Use will contain current hazardous classification information. Below is a general summary of these changes:

Product Labeling

The GHS hazard pictogram(s) with a red border will be added, and the orange hazard symbol and EU classification information will be removed

Signal word such as "DANGER" or "WARNING" will be added per the GHS

Risk phrases will be replaced by Hazard statements

Safety phrases will be replaced by Precautionary statements

Hazardous products may state new hazardous ingredients per the GHS classification

Addition of hazards not included within the GHS may be included as a pictogram or statement

Instructions For Use

Instructions For Use will change to align with labeling as mentioned in the label section Instructions For Use will have both previous hazard classification and new GHS hazard classification information during the period of transition

Safety Data Sheets

Section 2 will display hazard classification and information per the GHS

Section 15 will display previous hazard classification

Addition of hazards not included within the GHS may be included as a symbol or phrase

For further detailed information on the GHS, we encourage you to visit the Reference section at the bottom of this page. There you will find direct links to agency sites which provide in-depth information on the GHS, and all related requirements.

NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES.
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS

The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.

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